Changing the biotech patent game

by Le Xav’.

Appeals court strikes down another generic biotech patent
[Via Ars Technica]

Last week, the full US Appeals Court for the Federal Circuit upheld an earlier ruling by a partial panel, invalidating a biotech patent that originated in research at MIT and Harvard. The patent covered any of three ways to disable a signaling pathway involved in the immune response, and would have enabled its licensee, Ariad Pharmaceuticals, to go after companies that already have drugs on the market. The court held, however, that simply specifying different ways of interfering with a protein without any written description of how to do so constituted insufficient grounds for granting a patent.

This case, and a similar one (University of Rochester v. Pharmacia) that served as precedent, both followed a similar pattern. In each case, basic research in a university context identified a key protein involved in inflammatory responses. For Rochester, it was the enzyme Cox-2; drugs that inhibit it included Celebrex and Vioxx, both painkillers with lower risk of stomach irritation than aspirin. In the new case, it was the NF-kappaB signaling pathway, which is involved in the immune response to pathogens. Excessive activation of the NF-κB creates chronic inflammation. In this case, Eli Lilly had two drugs already on the market.

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Requiring biotech patent holders to actually describe how to, say, inhibit a pathway, with real details, could change the patent scenery tremendously. Currently, many patents are written with pretty weak descriptions of the “a small molecule inhibitor could be made.”

The appeals court said that is not enough and that there must be a real description of the inhibitor in order to hold the patent for that innovation. It used to be that being somewhat vague in a biotech patent extended its reach and provided more leverage. Now, not so much. If this court ruling stands.

While disruptive to some patents in the short run it should reward innovative drug development in the long run. Now it appears that the organization that actually produces the inhibitor will be rewarded rather than the group that simply said it could be done, without giving any details.

John Adams and his mandated insurance

by cliff1066™

The Political Economy of Mandated Health Benefits
[Via Grasping Reality with Both Hands]]

Paul J. O’Rourke reads us the news:

News: President Signs Health Care Insurance Mandate: A Lesson in American History, Healthcare and the Constitution for 14 State Attorneys General: Let’s begin today’s history lesson with the following news:

(CNN) — Officials from 14 states have gone to court to block the historic overhaul of the U.S. health care system that President Obama signed into law Tuesday, arguing the law’s requirement that individuals buy health insurance violates the Constitution. Thirteen of those officials filed suit in a federal court in Pensacola, Florida, minutes after Obama signed the Patient Protection and Affordable Care Act. The complaint calls the act an “unprecedented encroachment on the sovereignty of the states” and asks a judge to block its enforcement. “The Constitution nowhere authorizes the United States to mandate, either directly or under threat of penalty, that all citizens and legal residents have qualifying health care coverage,” the lawsuit states.

The history lesson

In July, 1798, Congress passed, and President John Adams signed into law “An Act for the Relief of Sick and Disabled Seamen,” authorizing the creation of a marine hospital service, and mandating privately employed sailors to purchase healthcare insurance. This legislation also created America’s first payroll tax, as a ship’s owner was required to deduct 20 cents from each sailor’s monthly pay and forward those receipts to the service, which in turn provided injured sailors hospital care. Failure to pay or account properly was discouraged by requiring a law violating owner or ship’s captain to pay a 100 dollar fine…. Perhaps these somewhat incompetent attorneys general might wish to amend their lawsuits to conform to the 1798 precedent, and demand that the mandate and fines be linked to implementing a federal single payer healthcare insurance plan. The other option is to name Presidents John Adams, Thomas Jefferson, James Madison et al. in the lawsuits. However, it might be difficult to convince a judge, or the public, that those men didn’t know the limits of the Constitution…. I’m providing a copy of the 5th Congress’ 1798 legislation.

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So, one of the Founding Fathers signed into law mandated insurance for some Americans that required the employer to collect money to pay for it. And there was a fine that had to be paid for failure to provide the insurance.

Precedent over 210 years old might be hard to overturn.